ColoSeal™ ICD System Safety and Feasibility Study

NCT06402188 | Recruiting FDA Device

• 1 other identifier: CLN0001
• Study Type: interventional
• Target: 15
• Locations: 3 countries
• Sites: 3

Brief Summary

The purpose of this clinical investigation is to evaluate the safety and feasibility of the ColoSeal ICD System in a prospective, multicenter, single-arm study. The ColoSeal ICD System is intended to be used to protect a damaged segment of colon such as a surgical anastomosis, anastomosis leak, or perforation from contact with fecal flow for up to 21 days. The device will be evaluated in adult patients with rectal and rectosigmoid cancer undergoing a resection with a colorectal anastomosis.

Conditions

Colorectal Cancer

Keywords

Colon anastomosis; Rectosigmoid cancer resection; Ostomy; Colon diversion

Outcome Measures

Primary Outcomes (1)

• Number of participants with device related adverse events

  Any device related adverse events during procedure and/or follow-up

  90 days post procedure

Secondary Outcomes (6)

• Procedure success

  Day 0

• Procedure time

  Day 0

• Migration rate

  Up to 21 days

• Occurrence of anastomotic leakage

  Up to 90 days post procedure

• Need for ostomy surgery

  Up to 90 days post procedure

Study Arms (1)

ColoSeal ICD Device Treatment Arm

EXPERIMENTAL

Subjects will undergo transanal placement of the ICD Device.

Device: ColoSeal ICD Device

Interventions

ColoSeal ICD Device DEVICE

The subject will undergo scheduled resection per the surgeon's preferred technique. Following completion of the anastomosis, the Intraluminal Colonic Diversion (ICD) Device will be inserted, advanced and positioned with the ICD Delivery System transanally. The ICD Device will remain in place for 10± 2 days. Anastomotic leak testing will be performed prior to scheduled removal.

ColoSeal ICD Device Treatment Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18-65 years of age at screening, or subject is 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed.
• Subject is diagnosed with rectosigmoid or rectal cancer
• Subject is scheduled for elective resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis and protective ostomy (anastomosis maximally 15 cm from the anal verge).
• The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).
• Subject must be willing and able to comply with study follow-up requirements.

You may not qualify if:

• Subject with a life expectancy \< 1 year
• Subjects with ASA classification \> 3
• Albumin \< 30 g/liter
• Subject has local or systemic infection at the time of intervention.
• Major surgical or interventional procedures within 30 days prior to this study or planned major surgical or interventional procedures within 1 month of entry into this study
• Patient has received systemic chemotherapy or radiation to the pelvis within 30 days prior to the planned procedure
• Subject has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis, diverticulitis, or extensively spread inflammatory bowel disease
• Subjects has a diagnosis of coagulopathy, thrombocytopenia, immune suppression
• BMI ≥ 40
• Subject is scheduled for a concurrent major surgical procedure during the surgery (e.g., liver resection)
• Subject has been taking regular systemic/ steroid medication in the last 3 months
• Subjects is taking antimetabolites or antiplatelet agents
• Subject has undergone a prior pelvic anastomosis
• Subject requires an end-to-end anastomosis smaller than 31 mm in diameter
• Known allergy to any component of the device

Sponsors & Collaborators

• Averto Medical, Inc.: lead

Study Sites (3)

National Center of Oncology after V.A. Fanarjian

Yerevan, Armenia

RECRUITING

Israeli-Georgian Medical Research Clinic Healthycore

Tbilisi, 0112, Georgia

COMPLETED

National Cancer Institute

Tashkent, Uzbekistan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Hurshid Djamshidovich, MD

  National Cancer Institute Tashkent Uzbekistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Carlson, MD

CONTACT

1-415-518-7043; grace.carlson@avertomed.com

Kenton Fong, MD

CONTACT

1-650-799-6298; kenton.fong@avertomed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: May 7, 2024
• Study Start: June 5, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1); GE (1); UZ (1)